I wonder if there are any that become more potent/dangerous after a period of time.
The Myth of Drug Expiration Dates
51–60 of 275 posts
Re: The Myth of Drug Expiration Dates
#52> The findings surprised both researchers: A dozen of the 14 compounds were still as potent as they were when they were manufactured, some at almost 100 percent of their labeled concentrations. What kind of reporting is this? Anything less than 100% is not "as potent as when manufactured", and the sentence implies some of those dozen weren't close to 100%. > The idea that drugs expire on specified dates goes back at…
> What kind of reporting is this? Anything less than 100% is not "as potent as when manufactured"
Relax, this is the real world, not a computer based series of 0s and 1s. Any such compound begins drifting off from the original specs as soon as it leaves the factory - and in a very real sense it's not exactly at 100% at any time post the moment of manufacture. The question is what kind of deviation can be tolerated.
Re: The Myth of Drug Expiration Dates
#53> The findings surprised both researchers: A dozen of the 14 compounds were still as potent as they were when they were manufactured, some at almost 100 percent of their labeled concentrations. What kind of reporting is this? Anything less than 100% is not "as potent as when manufactured", and the sentence implies some of those dozen weren't close to 100%. > The idea that drugs expire on specified dates goes back at…
When working with biological systems, most of the time your acceptable error margin is between 10-25%. There are a few compounds (like fentanyl or LSD) where the dosages are so small and the compound so potent that 10-25% makes a difference but for the majority, precision isn't that critical. The ones where it does matter are tightly controlled and clinically applied by a professional with active monitoring. The only…
Those 122 compounds were also over-representing publicly available products, as opposed to medically regulated compounds. You would need more rigor for a study where the compound efficacy actually mattered to make a general finding, across all classes of drugs. 25% difference in a beta blocker, glycerine, or blood thinner is a fatal change. These drugs are monitored with physical symptoms (metroprolol) and/or regular blood testing (sodium warafin/heparin/lovenox).
Re: The Myth of Drug Expiration Dates
#54"Berkowitz picks up a box of sodium bicarbonate, which is crucial for heart surgery and to treat certain overdoses. It’s being rationed because there’s so little available." Huh? US hospitals have a shortage of Baking Soda ?
Yes. One of 2 (or 3?) manufacturers in the US making it as a medical product had manufacturing issues, so there isn't enough of it that's cleared for medical use available.
EDIT: https://www.usatoday.com/story/money/2017/05/31/how-baking-s...
Re: The Myth of Drug Expiration Dates
#55"Berkowitz picks up a box of sodium bicarbonate, which is crucial for heart surgery and to treat certain overdoses. It’s being rationed because there’s so little available." Huh? US hospitals have a shortage of Baking Soda ?
Oh yes... it's a pain in the ass. Recently in the news, too [1].
There weren't many days where the hospitals I've worked at weren't short on something. (And these are like, big name academic medical centers in big U.S. cities.) I've run into a shortage of normal saline before. Yes... salt water.
Sometimes hospitals will even stockpile basic supplies to keep from running into shortages... which only makes the whole situation worse.
It causes a lot of patient harm, even if it's usually not catastrophic because we usually have redundant meds. Recently my hospital was out of a common, generic, cheap antibiotic. For many infections in many patients, this meant we had to switch to the second-line drug -- which was more expensive, had more side effects, and was less effective against the bug. This type of thing happens to chemo drugs, to drugs you give after a heart attack, to drugs you need for planned surgeries or procedures.
I don't know how to solve this. Less regulation? More regulation? Subsidies for manufacturers of essential medications / supplies? I mean, normal saline is already ridiculously expensive enough [2].
For more reading: http://news.medill.northwestern.edu/chicago/hospital-drug-sh...
[1]: https://www.nytimes.com/2017/05/21/health/sodium-bicarbonate...
[2]: http://www.nytimes.com/2013/08/27/health/exploring-salines-s...
Re: The Myth of Drug Expiration Dates
#56Earlier quoted context omitted.
When working with biological systems, most of the time your acceptable error margin is between 10-25%. There are a few compounds (like fentanyl or LSD) where the dosages are so small and the compound so potent that 10-25% makes a difference but for the majority, precision isn't that critical. The ones where it does matter are tightly controlled and clinically applied by a professional with active monitoring. The only…
And to add into that, dosage studies are rarely adequately done for most drugs. The dose we take is often a best guess and may be twice or more than we need, so 10% is even more inconsequential.
This is completely wrong.
Dosage studies happens between Phase 2 and Phase 3 trials (and Phase 4 "post marketing" too) and are the most expensive, longest and most scientific process that arguably any business engages in in the entire world.
Phase 1 is a safety test in healthy ~men. These seek to find the maximum dose before adverse effects appear in the healthiest humans.
Phase 2 is a safety/dosage test in a much larger and varied sample. We know dose ranges and begin testing them for efficacy in a varied population.
Phase 3 is the big one. It's a randomized, controlled, double blind test of SPECIFIC dosages in SPECIFIC target populations to scientifically prove efficacy over placebo.
The dose we take is not a "BEST GUESS"
It is the result of a billion dollars of scientific study and that PRECISE NME (new molecular entity) has been studied, at that PRECISE dose, in a target population, for it's effectiveness, and it must be better than existing-treatments and better than placebo.
It should be highlighted that this process takes on average 10 years, costs $1 billion dollars, and has a success rate (success meaning FDA approval) of about 1 in 10,000 attempts (hence the price tag).
Source: Drugs: From Discovery to Approval, Second Edition http://onlinelibrary.wiley.com/book/10.1002/9780470403587
Re: The Myth of Drug Expiration Dates
#57> But neither Cantrell nor Dr. Cathleen Clancy, associate medical director of National Capital Poison Center, a nonprofit organization affiliated with the George Washington University Medical Center, had heard of anyone being harmed by any expired drugs. Cantrell says there has been no recorded instance of such harm in medical literature. I am more than a little surprised by this. Fanconi syndrome, a kidney disease t…
I was going to post a similar reply. However, outside of tetracycline, there have never been reported adverse effects from expired drugs. Furthermore, there were only three cases of expired tetracycline related Fanconi Syndrome and that preparation responsible is no longer made. Of course, if it's old...
Otherwise I agree I'm surprised by the reporting ignoring this because this is a classic board question in internal medicine.
Source: http://www.mdedge.com/internalmedicinenews/article/113748/sh...
Edit: Apologies that the above link has a paywall. When I accessed it via google it worked once, then shot up a paywall. If it doesn't work at all I'll remove it.
Re: The Myth of Drug Expiration Dates
#58Earlier quoted context omitted.
And to add into that, dosage studies are rarely adequately done for most drugs. The dose we take is often a best guess and may be twice or more than we need, so 10% is even more inconsequential.
This is completely wrong. Dosage studies happens between Phase 2 and Phase 3 trials (and Phase 4 "post marketing" too) and are the most expensive, longest and most scientific process that arguably any business engages in in the entire world. Phase 1 is a safety test in healthy ~men. These seek to find the maximum dose before adverse effects appear in the healthiest humans. Phase 2 is a safety/dosage test in a much la…
Do all 10,000 attempts go through all the testing? Or are many weeded out before $1 billion has been spent?
Re: The Myth of Drug Expiration Dates
#59"Berkowitz picks up a box of sodium bicarbonate, which is crucial for heart surgery and to treat certain overdoses. It’s being rationed because there’s so little available." Huh? US hospitals have a shortage of Baking Soda ?
Medical grade baking soda, yes: https://arstechnica.com/science/2017/05/baking-soda-shortage...
You can't just take a box from the baking supplies shelf in Walmart.
Re: The Myth of Drug Expiration Dates
#60> The findings surprised both researchers: A dozen of the 14 compounds were still as potent as they were when they were manufactured, some at almost 100 percent of their labeled concentrations. What kind of reporting is this? Anything less than 100% is not "as potent as when manufactured", and the sentence implies some of those dozen weren't close to 100%. > The idea that drugs expire on specified dates goes back at…
When working with biological systems, most of the time your acceptable error margin is between 10-25%. There are a few compounds (like fentanyl or LSD) where the dosages are so small and the compound so potent that 10-25% makes a difference but for the majority, precision isn't that critical. The ones where it does matter are tightly controlled and clinically applied by a professional with active monitoring. The only…
>your acceptable error margin is between 10-25%
10-25 percent of....what?